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Completed

NCT Number: NCT04770909

Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity

This study involves an evaluation of whether providing small incentives weekly for dietary self-monitoring and/or weight loss improves short- and long-term weight loss. Participants can expect to be on study for 18 months.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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About this study

In this two-site, randomized, single-masked, longitudinal 2x2 factorial study, called Log2Lose, adults with obesity from Madison, WI and Durham, NC will be offered a 78 week, evidence-based behavioral weight management program comprising an incentivized weight loss intervention for 26 weeks (Phase I), an incentivized weight loss maintenance intervention for 26 weeks (Phase II), and a non-incentivized weight maintenance intervention for 26 weeks (Phase III). Participants will be randomized in a 2x2 design to receive adjunctive incentives for either weekly weight loss or dietary self-monitoring, both, or neither. The investigators will assess the proportion of participants achieving clinically significant weight loss of greater than or equal to 5 percent at the end of each phase.

All participants will participate in an 18-month weight management program delivered via videoconference.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥30 kg/m2
  • Desire to lose weight
  • Agrees to attend outcome visits per protocol
  • Available for class times
  • Transportation and ability to attend in-person study visits at baseline (screening), 26, 52, and 78 weeks
  • Able to stand for weight measurements without assistance
  • Able to speak and read English
  • Able to download and use the MyFitnessPal and Fitbit apps daily
  • Possess smart phone with data and texting plan
  • Have or willing to create a Gmail address
  • Able to connect to a video conference call using a smartphone, tablet or computer with a webcam and microphone
  • Score of at least 4 out of 6 on a validated cognitive screener

Exclusion criteria

  • Weight >380 lb
  • Weight loss of at least 10 lbs in the month prior to screening
  • Currently enrolled or enrolled in previous month in a clinical, research, or community program focusing on lifestyle change that could affect weight
  • Current use of weight loss medication
  • History of bariatric surgery or planning to have bariatric surgery in the study timeframe
  • Residing in a nursing home or receiving home health care
  • Impaired hearing
  • Significant dementia, drug or alcohol misuse, or unstable psychiatric illness (e.g., schizophrenia, psychosis)
  • Current treatment for cancer or being treated for cancer (besides basal cell carcinoma or squamous cell) in the last 6 months
  • Use of insulin, sulfonylureas, or meglitinides due to increased risk for hypoglycemia
  • Pregnant, breastfeeding, or planning to become pregnant within the study timeframe
  • Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, torsemide 20 mg daily, bumetanide 1 mg daily, or any use of metolazone; use of potassium-sparing diuretics is acceptable
  • Chronic kidney disease at stage 4 or 5
  • Unstable heart disease in the 6 months prior to screening
  • Exertional chest pain
  • History of ascites requiring paracentesis
  • Pain, fainting or other conditions that prohibit mild/moderate exercise

Treatment and study plan

Incentives for dietary self-monitoring and weight loss

Behavioral

Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss

Incentives for dietary self-monitoring

Behavioral

Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring

Incentives for weight loss

Behavioral

Participants can earn up to $300 during the trial for achieving weight loss

Primary outcomes

  1. Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 26 Weeks

    Time frame: 26 weeks

    Measured on a calibrated, digital scale to the nearest 0.1 kg

Secondary outcomes

  1. Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 52 Weeks

    Time frame: 52 weeks

    Measured on a calibrated, digital scale to the nearest 0.1 kg

  2. Percent of Participants Who Achieve Clinically Significant Weight Loss of at Least 5 Percent of Baseline Weight at 78 Weeks

    Time frame: 78 weeks

    Measured on a calibrated, digital scale to the nearest 0.1 kg

  3. Change in Use of Cardiovascular Medications From Baseline to 78 Weeks for All Participants

    Time frame: Baseline, 78 weeks

    Antihypertensive, antilipemic, and type 2 diabetes medications use reported here descriptively as the count of participants who decreased medications, increased medications, or where medications stayed the same.

  4. Change in Use of Cardiovascular Medications From Participants Who Took 1 or More Medications From Baseline to 78 Weeks

    Time frame: Baseline, 78 weeks

    Antihypertensive, antilipemic, and type 2 diabetes medication use, reported here descriptively as the count of participants with any medications who decreased medications, increased medications, or where medications stayed the same.

  5. Diastolic Blood Pressure

    Time frame: baseline, 26, 52, and 78 weeks

    Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the *systolic* measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading. Data are model estimated means, baseline values are the same for all groups.

  6. Systolic Blood Pressure

    Time frame: 26, 52, and 78 weeks

    Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading. Data are model estimated means, baseline values are the same for all groups.

Other outcomes

  1. Intrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire

    Time frame: 26 weeks

    Association of intrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire. Intrinsic motivation will be calculated as mean of items 2, 4, 6, 8, 11, 14, 16, 17. Each item can be answered from '1 - not at all true' to '6 - very true'. Lower scores correspond to lower intrinsic motivation for weight loss

  2. Extrinsic Motivation for Weight Loss as Assessed by Modified Treatment Self-Regulation Questionnaire

    Time frame: 26 weeks

    Association of extrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire.

    Extrinsic motivation will be calculated as mean of items 1, 3, 5, 7, 9, 10, 12, 13, 15, 18. Each item can be answered from '1 - not at all true' to '6 - very true'. Lower scores correspond to lower extrinsic motivation for weight loss

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 25, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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